Advanced Materials A Review of What is Applicable in SUT

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1 Advanced Materials A Review of What is Applicable in SUT Amy Plancon, Jayanthi Grebin, and James Hicks Panel Organizer: Eva Heintz, Ph.D.

2 Thermoplastics: General Polyolefins Amy Plancon Sabic July 14, 2017

3 POLYETHYLENE (C2)

4 POLYPROPYLENE (C3)

5 LDPE & PP Offer a range of properties, and may be suitable for a wide range of applications Versatile materials Depends on polymer type and additives Some materials such as LDPE can be made additive-free, depending on polymerization process Can meet pharmacopoeia standards (EP, USP, DMF)

6 POLYCARBONATE High impact strength Inherent water-clear transparency High heat resistance Unlimited colors transparent, translucent, opaque FDA & Biocompatibility Very good processability and design versatility Multiple sterilization options

7 CHEMICAL PROPERTIES: TYPES OF ADDITIVES Modifiers Impact modifiers Nucleating agents/clarifiers Organic peroxides Plasticizers Property Extenders Antioxidants Antistatic agents Heat stabilizers Light stabilizers Processing Aids Anti-blocking agents Lubricants/mold release Slip agents Improves film toughness Inhibits gels Increases gamma stability Facilitates bag opening Minimizes blocking Additives are used to improve processing of polymers and to enhance their properties

8 SUMMARY Input Process Output (SUT) LDPE HDPE PP PC Additives Injection molding Extrusion Film (blown, cast) Printing Filling Sterilization Mechanical Modulus Impact Rupture Chemical Extractables & leachables Single Use Technology Influencing Single Use Technology

9 Thermoplastics: Fluoropolymers Jayanthi Grebin & Mike Johnson Entegris July 14, 2017

10 Fluoropolymer Applications Consumer Electronics Food Processing Industrial Coatings Semiconductor Manufacturing Source: ASME-BPE 2016

11 Single-Use Innovation Source: ASME-BPE 2016 Source: ASME-BPE 2016

12 Polytetrafluoroethylene or PTFE (1938) PTFE, later trademarked as Teflon, was discovered by Dr. Roy Plunkett in The fluorine atoms prefer their own kind, drawing to each other while repelling other kinds of molecules. Fluorine Carbon Fluorine C-C and C-F bonds are among the strongest in single bond organic chemistry, accounting for many of its unique properties. F C F F C F n Source: Teflon is a trademark of The Chemours Company.

13 Fluoropolymers Nonstick Low coefficient of friction Wide Temperature resistance Unique electrical properties Cryogenic stability Universal chemical resistance

14 Chemical Resistance Fluoropolymers unmatched chemical resistance is suitable for just about any pharmaceutical or bioprocessing application Strong mineral acids Inorganic bases Salt solutions Organic acids Alcohols Esters Aldehydes

15 Temperature Use Range ( C) Fluoropolymer PVDF EVA HDPE PP Source: Compass Publications Chemical Resistance Guide for Plastics, 2000

16 Polymer Compounds Potential sources of E&L in many polyolefins Polymer additives Antioxidants Photostabilizers Plasticizers Lubricants Acid scavengers Pigments/colorants Cross linking agents Adhesives (i.e. tie layer) Catalysts Polyester (PET) Layer Tie Layer EVOH Layer Tie Layer ULDPE Contact Layer

17 Polymer Compounds Potential sources of E&L in fluoropolymers Polymer additives Antioxidants Photostabilizers Plasticizers Lubricants Acid scavengers Pigments/colorants Cross linking agents Adhesives Catalysts Fluoropolymer Contact Layer

18 Summary Compatibility Outperforms other polymers as very few chemicals have an effect on fluoropolymers Extractables No additives to base resin result in extremely low extractable profile Strength Maintains mechanical properties across a wide range of process temperatures

19 Thermoplastics: High Performance Aromatic Based Polymers and High Barrier PVDC James Hicks Solvay Specialty Polymers July 14, 2017

20 A Review of the Categories of Thermoplastics Commodity Polymers PE, PP, PVC, PS >75% of manufactured polymers are in this category. Engineered Polymers PC, ABS, PA, PEX, PET High structural properties and/or other unique properties not available with commodity polymers. High Performance Polymers PSU, PES, PPSU, PARA, PPA Engineered polymers taken to the next level. Ultra Polymers PEEK, PAI Specially design polymers capable of meeting multiple demanding criteria. PVC polymer base Nylon (PA) polymer base Sulfone polymer base PEEK polymer base

21 Conversion to High Performance Plastics COMMODINITY AND ENGINEERING PLASTICS Increase Chemical Resistance Increase Mechanical Performance Increased Thermal Performance ULTRA AND HIGH PERFORMANCE PLASTICS METALS Increase Chemical Resistance Acidic or Alkaline conditions Lower Costs to manufacture Weight Reduction Consolidation of parts

22 Drivers for Thermoplastics to Metal Conversions Weight / Ergonomics Colorability / Transparency Design flexibility Part consolidation Lower cost manufacturing

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24 Sterilization Methods Steam (up to 134 C for 18 minutes) Ethylene Oxide Hydrogen Peroxide Gamma Radiation 10 cycles 500 cycles 1,000 cycles 100 cycles 200 cycles kgy PC - Polycarbonate PARA Aromatic Nylon PSU - Polysulfone PPSU - Polyphenylsulfone PEEK - Polyetheretherketone Not all Plastics can Withstand a wide range of Sterilization Methods

25 Sulfone and PEEK based polymers - Compliance Profile Most base grades have: EU Regulation No 10/2011 on plastic materials and articles intended to come into contact to foodstuffs (2) U.S.: approvals for Food and Drug Administration (FDA) 21 CFR Part (1) USP VI Compliance ISO Complaince (2) NSF Std 51 and 61 Low extractables and leachables 1) Information on current listings for specific grades is available from your Solvay representative 2) Sectional complaince varies with product and grades

26 Polyvinylidene Chloride - PVDC: Strong Properties by Chemistry Steric hindrance: Crystallinity: H 2 O Vapor Barrier Polarity: O 2 Barrier HF Sealability Salt Oil Source: Statoil Optional: Ethylene via Biomass Source: brasilien.de H Cl C C H Cl VDC-Monomer Polymerization X Comonomer(s) H ( ) C C ( X ) H Cl Cl Flame Resistance: High LOI Functionality: Printability Adhesion Copolymer: Tailor-made Low melt T: Low Tg: Thermoforming Shrink Flexibility Heat Sealability

27 Oxygen and Water Vapor Comparison Oxygen Dry: 25 ºC/ 0% rel. humidity cm 3 µm/ (m² d bar) 1) Water Vapor 38 ºC / 90% rel. humidity g µm / (m² d) 1) LDPE HDPE OPP R-PVC PA 6-6 PETP PAN EVOH (EVAL) Cellophane PVOH (PVAL) ca ca ca ca ca ca. 800 PVDC ca > ) Film thickness: 1 µm (= intrinsic permeability) PVDC provides both outstanding water vapor and oxygen barrier

28 PVDC - Compliance Profile U.S.: PVDC approvals for Food and Drug Administration (FDA) 21 CFR Part (1) European Pharmacopeia EU Regulation No 10/2011 on plastic materials and articles intended to come into contact to foodstuffs (2) 1) Information on current listings for specific grades is available from your Solvay representative 2) Including EU Regulation No 1282/2011